Suzhou Pac-Dent Technology Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 26 device types.
Suzhou Pac-Dent Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Needle, Dental, Dress, Surgical and 24 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | Suzhou Pac-Dent Technology Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004046477 |
| FEI number | 3004046477 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 苏州派克顿科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Building 1: Floor 1, 2, 4 of Area A & Area C, Area B, Building 3, Building 5; 51 Zhousidun Road, Caohu Street |
| Postal code | 215000 |
| Country | China |
Group
Suzhou Pac-Dent Technology Co., Ltd. is one of 2 plants registered under Pac-Dent Inc..
| Plant | City | Device types |
|---|---|---|
| iBrite Suzhou Technology Co., Ltd. | Suzhou | 18 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Retractor, Dental | Class 1 | 2017 | 37 | |
| Cover, Barrier, Protective | Class 2 | 2022 | 15 | |
| Cup, Prophylaxis | Class 1 | AntiSplatr™ Disposable Prophy Angles | 2017 | 49 |
| Dental Barriers And Sleeves | Class 2 | Pac-Dent Barrier Sleeve, Cover It Barrier Film, Universal Curing Light Shield, Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers, Air Techniques, PSP Barrier Envelopes, Dental barriers and sleeves | 2017 | 12 |
| Dress, Surgical | Class 1 | 2017 | 71 | |
| Evacuator, Oral Cavity | Class 1 | 2017 | 49 | |
| File, Pulp Canal, Endodontic | Class 1 | JS Dental | 2017 | 53 |
| Handle, Instrument, Dental | Class 1 | 2017 | 29 | |
| Handpiece, Contra- And Right-Angle Attachment, Dental | Class 1 | ProMate, Freestyle Pro, ProAngle, ProMate™ EZ-Q Quick Disconnect Combo- Hygiene Handpiece and Coupler, AntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup, 1,200ct, Acclean Ergo Prophy Angle LF and 6 more | 2017 | 9 |
| Heat Source For Bleaching Teeth | Class 1 | 2017 | 56 | |
| Holder, Film, X-Ray | Class 1 | 131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk, 131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk, 131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk, 131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk, 131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk, 131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk and 4 more | 2017 | 40 |
| Instruments, Dental Hand | Class 1 | PJ-01 ProJect™ Composite Dispensing Gun | 2017 | 64 |
| Material, Impression Tray, Resin | Class 1 | Rodin TruModel | 2017 | 41 |
| Mixer, Cement, For Clinical Use | Class 1 | Composite Spatulas Plastic | 2017 | 14 |
| Needle, Dental | Class 1 | 2017 | 56 | |
| Retainer, Matrix | Class 1 | iMatrix Clear | 2017 | 13 |
| Retractor, All Types | Class 1 | EasyProp | 2017 | 45 |
| Scaler, Periodontic | Class 1 | 2017 | 34 | |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | 2017 | 384 | |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | 2017 | 32 | |
| Syringe, Restorative And Impression Material | Class 1 | 2017 | 49 | |
| Tray, Fluoride, Disposable | Class 1 | Pac-Dent Disposable Tray, Tooth Whitening | 2017 | 22 |
| Tray, Impression, Preformed | Class 1 | 2017 | 73 | |
| Unit, Operative Dental, Accessories | Class 1 | 2017 | 65 | |
| Unit, Syringe, Air And/Or Water | Class 1 | 2017 | 56 | |
| Wheel, Polishing Agent | Class 1 | 2017 | 15 |
Clearances
No clearance names Suzhou Pac-Dent Technology Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K160232 | 2016-06-07 | PEM | Traditional | Dentsply LLC |
| K030603 | 2003-04-14 | EGS | Traditional | Pac-Dent International (Suzhou), Ltd. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.